MAUDE Adverse Event Report: PAJUNK GMBH MEDIZINTECHNOLOGIE SONOPLEX II FACET S; NEEDLE, CONDUCTION, ANESTHETIC (W/WO INTRODUCER)

Model Number 001287-71

Device Problem Physical Resistance/Sticking (4012)

Patient Problem Insufficient Information (4580)

Event Date 08/06/2021

Event Type  malfunction  

Event Description

Patient, admitted to the or, having left-sided rs and tap block for laparoscopic liver surgery.The pajunk gmbh medizintechnologie sonoplex ii facet s 22g/80mm nerve block needle appears to have malfunctioned (ref # (b)(4), lot #1394.10).The needle was pre-primed with medication and tubing was attached to a 30ml syringe.Needle was guided into the correct position.Aspiration was negative.Needle would not inject.Tubing wasn't kinked.No evidence of debris in syringe.Multiple care givers attempted to depress the plunger on the syringe without success.Needle was withdrawn and replaced with a new device.Block was completed successfully.Device and packaging have been saved.This is a contaminated sharp that is sheathed.Item can be provided to materials if needed.This is the second time this exact incident with this product has occurred at the medical center.Writing the report so it can be tracked if it happens again.

• Brand Name: SONOPLEX II FACET S
• Type of Device: NEEDLE, CONDUCTION, ANESTHETIC (W/WO INTRODUCER)
• Manufacturer (Section D): PAJUNK GMBH MEDIZINTECHNOLOGIE; 6611 bay circle, suite 140; norcross GA 30071
• MDR Report Key: 12473835
• MDR Text Key: 271475867
• Report Number: 12473835
• Device Sequence Number: 1
• Product Code: BSP
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Type of Report: Initial
• Report Date: 09/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 001287-71
• Device Catalogue Number: 001287-71
• Device Lot Number: 1394.10
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/03/2021
• Event Location: Hospital
• Date Report to Manufacturer: 09/15/2021
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/15/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1